There is a high incidence of candidaemia and a substantial burden of comorbidities among neonates as confirmed in a recent nationwide epidemiologic study of paediatric candidaemia. An increasing proportion of nonalbicans species resistant to fluconazole has also been observed.

A study done in Sweden suggests that foetal exposure to maternal infections may increase the risk of autism and depression in the offspring.

Original New Drug Application Approvals by US FDA (1 - 15 October 2018)

15 Oct 2018

New drug applications approved by US FDA as of 1-15 October 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

SEYSARA

Active Ingredient(s): Sarecycline

Strength: 60 mg, 100 mg, 150 mg

Dosage Form: Tablet; oral

Company: Allergan Inc

Approval Date: October 01, 2018

Submission Classification: Type 1 - New Molecular Entity

Indication(s): Indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.

There is a high incidence of candidaemia and a substantial burden of comorbidities among neonates as confirmed in a recent nationwide epidemiologic study of paediatric candidaemia. An increasing proportion of nonalbicans species resistant to fluconazole has also been observed.